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Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance

Primary Purpose

Impaired Glucose Tolerance

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Subetta
Placebo
Sponsored by
Materia Medica Holding
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Outpatients aged 18 to 70 years.
  2. Impaired glucose tolerance (plasma glucose from 7.8 to 11.0 mmol / L 2 hours after a 75 g oral glucose consumption during an oral glucose tolerance test, while fasting plasma glucose <7.0 mmol / L).
  3. HbA1c is 5.7-6.4%.
  4. The body mass index is 25.0-39.9 kg / m^2.
  5. Consent to use reliable contraceptive methods during the study (for men and women with reproductive potential).
  6. The presence of the signed informed consent form to participate in the clinical trial.

Exclusion Criteria:

  1. Type 1 or type 2 diabetes.
  2. Use of any medications indicated in the section "Prohibited concomitant medications".
  3. Acute or exacerbation / decompensation of a chronic disease of any etiology at the time of the examination or during the previous week.
  4. Uncontrolled arterial hypertension with blood pressure: systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 110 mm Hg.
  5. Acute coronary syndrome, myocardial infarction, acute impairment of cerebral circulation during the previous 6 months prior to enrollment.
  6. Unstable or life-threatening arrhythmia during the previous 3 months prior to enrollment.
  7. Acute and chronic heart failure with functional class III or IV (according to the classification of the New York Heart Association, 1964).
  8. Respiratory failure.
  9. Chronic kidney disease (classes C3-5 A3).
  10. Hepatic insufficiency (class C according to Child-Pugh).
  11. Presence or suspicion of oncology disease.
  12. The presence of an allergy / hypersensitivity to any component of the medication administered during the treatment.
  13. Alcohol consumption > 2 alcohol units for males and > 1 alcohol unit for females per day.
  14. Mental illness or drug abuse in anamnesis.
  15. Bariatric surgery in anamnesis, any surgery for 3 months before enrollment.
  16. Pregnancy, breast-feeding; childbirth less than 3 months before enrollment.
  17. Participation in other clinical trials for 3 months before enrollment in this study.
  18. Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
  19. Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).

Sites / Locations

  • Arkhangelsk Regional Clinical Hospital
  • Belgorod State National Research University
  • Ural State Medical University
  • City Clinical Hospital #40
  • Central City Hospital #7
  • Kirov Clinical Hospital № 7 named. V.I. Yurlova
  • Kuban State Medical University
  • Regional Clinical Hospital #1 named after Professor Ochapovsky
  • Clinic of Professor Gorbakov
  • Krasnogorsk city hospital №1
  • City Clinical Hospital named after F.I. Inozemtseva Department of Health of Moscow
  • City Clinical Hospital named after V.P. Demikhova
  • Moscow Clinical Scientific and Practical Center of the Moscow City Health Department
  • The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences
  • Pirogov Russian National Research Medical University
  • Federal State Institution "Polyclinic No. 5" of the Administrative Department of the President of the Russian Federation
  • National Medical Research Center for Rehabilitation and Balneology
  • LLC Clinic "Bessalar"
  • Moscow State University of Medicine and Dentistry
  • City Clinical Hospital No. 10 of the Kanavinsky District of Nizhny Novgorod
  • Semashko Nizhny Novgorod Regional Clinical Hospital
  • LLC "Medical Center "Healthy Family"
  • Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences
  • Novosibirsk State Medical University
  • Rostov State Medical University
  • Polyclinic Complex JSC
  • City Clinical Hospital #109
  • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 25"
  • Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy named after S.M. Kirov Defense Ministry of the RF/Department and clinic of field therapy
  • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
  • St. Petersburg State Budgetary Institution of Health "City Polyclinic № 54"
  • Road Clinical Hospital JSC Russian Railways
  • Pavlov First Saint Petersburg State Medical University
  • Limited Liability Company Gastroenterologichesky Center Expert
  • St. Petersburg State Budgetary Institution of Health "City Polyclinic № 106"
  • Pokrovskaya City Hospital
  • St. Petersburg State Budgetary Institution of Health "City Polyclinic №4"
  • Samara city hospital #4
  • LLC Center "Diabetes"
  • Saratov State Medical University named after V. I. Razumovsky
  • Volgograd State Medical University
  • Voronezh Regional Clinical Consultative and Diagnostic Center
  • LLC "Medical Consultations and Research Center - PRACTICE"
  • The State Budgetary Healthcare Institution of the Yaroslavl Region "Regional Clinical Hospital"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Subetta

Placebo

Arm Description

Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.

Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.

Outcomes

Primary Outcome Measures

Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).
Based on medical records. For oral glucose tolerance test, the subject is given 75 g of oral glucose and blood sample is taken 2 hours later. All analysis will be done in a central laboratory.

Secondary Outcome Measures

Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.
Based on medical records.
Change in Fasting Plasma Glucose.
Based on medical records. Fasting plasma glucose is measured after fasting or not eating anything for at least 8 hours.
Change in HbA1c
Based on medical records. HbA1c is determined by the method certified in accordance with National Glycohemoglobin Standardization Program and standardized in compliance with the reference values adopted in the Diabetes Control and Complications Trial.

Full Information

First Posted
October 29, 2018
Last Updated
January 14, 2021
Sponsor
Materia Medica Holding
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1. Study Identification

Unique Protocol Identification Number
NCT03725033
Brief Title
Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
Official Title
Multicentre Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Materia Medica Holding

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Purpose of the study: to assess the efficacy of Subetta in the treatment of impaired glucose tolerance to assess the safety of Subetta in the treatment of impaired glucose tolerance.
Detailed Description
Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized trial. The study will enroll outpatients adults aged 18 to 70 years with impaired glucose tolerance (IGT) who did not receive glucose-lowering agents previously. Persons with pre-diabetes, obesity (especially with visceral or abdominal obesity), dyslipidemia (with high triglycerides and/or low-density lipoproteins), hypertension, diabetes in first-degree relatives will be considered as potential candidates to participate in the study. After the patient's information sheet and the form of informed consent for participation in the study are signed on the screening (visit 0; day from -7 to 0), complaints and history are collected, registration of concomitant conditions and diseases, objective examination, calculation of body mass index (BMI), oral glucose tolerance test (OGTT), fasting blood glucose. Furthermore, blood samples (for testing HbA1c, chemistry and hematology, HLA genotyping) and urine sample will be collected; concomitant therapy will be recorded, diet and physical activity recommendations will be given. All women of childbearing potential will be administered pregnancy tests. If eligibility criteria are met and there are no non-inclusion criteria on Visit 1 (Day 1), the patient is randomized to one of two groups: the Subetta group (patients will take 2 tablets twice a day for 12 weeks) or placebo group (patients will take a placebo according to the scheme of Subetta for 12 weeks). In the course of the study, two more visits in 4 (Visit 2) and 12 (Visit 3) weeks are planned, during these weeks complaints are recorded, a patient's examination is recorded, therapy compliance and safety are assessed. On Visit 3 OGTT, fasting blood glucose, blood samples (for HbA1c, chemistry and hematology) and urinalysis will be performed. The duration of observation period shall be up to 13 weeks. During the study the treatment for underlying conditions will be allowed with the exception of the drugs indicated in the section "Prohibited concomitant therapy".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
538 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subetta
Arm Type
Experimental
Arm Description
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
Intervention Type
Drug
Intervention Name(s)
Subetta
Intervention Description
Oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration.
Primary Outcome Measure Information:
Title
Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).
Description
Based on medical records. For oral glucose tolerance test, the subject is given 75 g of oral glucose and blood sample is taken 2 hours later. All analysis will be done in a central laboratory.
Time Frame
At baseline and after 12 weeks of treatment.
Secondary Outcome Measure Information:
Title
Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.
Description
Based on medical records.
Time Frame
After 12 weeks of treatment.
Title
Change in Fasting Plasma Glucose.
Description
Based on medical records. Fasting plasma glucose is measured after fasting or not eating anything for at least 8 hours.
Time Frame
At baseline and after 12 weeks of treatment.
Title
Change in HbA1c
Description
Based on medical records. HbA1c is determined by the method certified in accordance with National Glycohemoglobin Standardization Program and standardized in compliance with the reference values adopted in the Diabetes Control and Complications Trial.
Time Frame
At baseline and after 12 weeks of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients aged 18 to 70 years. Impaired glucose tolerance (plasma glucose from 7.8 to 11.0 mmol / L 2 hours after a 75 g oral glucose consumption during an oral glucose tolerance test, while fasting plasma glucose <7.0 mmol / L). HbA1c is 5.7-6.4%. The body mass index is 25.0-39.9 kg / m^2. Consent to use reliable contraceptive methods during the study (for men and women with reproductive potential). The presence of the signed informed consent form to participate in the clinical trial. Exclusion Criteria: Type 1 or type 2 diabetes. Use of any medications indicated in the section "Prohibited concomitant medications". Acute or exacerbation / decompensation of a chronic disease of any etiology at the time of the examination or during the previous week. Uncontrolled arterial hypertension with blood pressure: systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 110 mm Hg. Acute coronary syndrome, myocardial infarction, acute impairment of cerebral circulation during the previous 6 months prior to enrollment. Unstable or life-threatening arrhythmia during the previous 3 months prior to enrollment. Acute and chronic heart failure with functional class III or IV (according to the classification of the New York Heart Association, 1964). Respiratory failure. Chronic kidney disease (classes C3-5 A3). Hepatic insufficiency (class C according to Child-Pugh). Presence or suspicion of oncology disease. The presence of an allergy / hypersensitivity to any component of the medication administered during the treatment. Alcohol consumption > 2 alcohol units for males and > 1 alcohol unit for females per day. Mental illness or drug abuse in anamnesis. Bariatric surgery in anamnesis, any surgery for 3 months before enrollment. Pregnancy, breast-feeding; childbirth less than 3 months before enrollment. Participation in other clinical trials for 3 months before enrollment in this study. Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted). Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).
Facility Information:
Facility Name
Arkhangelsk Regional Clinical Hospital
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Belgorod State National Research University
City
Belgorod
ZIP/Postal Code
308015
Country
Russian Federation
Facility Name
Ural State Medical University
City
Ekaterinburg
ZIP/Postal Code
620026
Country
Russian Federation
Facility Name
City Clinical Hospital #40
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Central City Hospital #7
City
Ekaterinburg
ZIP/Postal Code
620137
Country
Russian Federation
Facility Name
Kirov Clinical Hospital № 7 named. V.I. Yurlova
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
Facility Name
Kuban State Medical University
City
Krasnodar
ZIP/Postal Code
350063
Country
Russian Federation
Facility Name
Regional Clinical Hospital #1 named after Professor Ochapovsky
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Clinic of Professor Gorbakov
City
Krasnogorsk
ZIP/Postal Code
143405
Country
Russian Federation
Facility Name
Krasnogorsk city hospital №1
City
Krasnogorsk
ZIP/Postal Code
143408
Country
Russian Federation
Facility Name
City Clinical Hospital named after F.I. Inozemtseva Department of Health of Moscow
City
Moscow
ZIP/Postal Code
105187
Country
Russian Federation
Facility Name
City Clinical Hospital named after V.P. Demikhova
City
Moscow
ZIP/Postal Code
109263
Country
Russian Federation
Facility Name
Moscow Clinical Scientific and Practical Center of the Moscow City Health Department
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences
City
Moscow
ZIP/Postal Code
117593
Country
Russian Federation
Facility Name
Pirogov Russian National Research Medical University
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Federal State Institution "Polyclinic No. 5" of the Administrative Department of the President of the Russian Federation
City
Moscow
ZIP/Postal Code
119121
Country
Russian Federation
Facility Name
National Medical Research Center for Rehabilitation and Balneology
City
Moscow
ZIP/Postal Code
121099
Country
Russian Federation
Facility Name
LLC Clinic "Bessalar"
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Moscow State University of Medicine and Dentistry
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
City Clinical Hospital No. 10 of the Kanavinsky District of Nizhny Novgorod
City
Nizhny Novgorod
ZIP/Postal Code
603011
Country
Russian Federation
Facility Name
Semashko Nizhny Novgorod Regional Clinical Hospital
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
LLC "Medical Center "Healthy Family"
City
Novosibirsk
ZIP/Postal Code
630061
Country
Russian Federation
Facility Name
Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences
City
Novosibirsk
ZIP/Postal Code
630090
Country
Russian Federation
Facility Name
Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Polyclinic Complex JSC
City
Saint Petersburg
ZIP/Postal Code
190013
Country
Russian Federation
Facility Name
City Clinical Hospital #109
City
Saint Petersburg
ZIP/Postal Code
192283
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 25"
City
Saint Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy named after S.M. Kirov Defense Ministry of the RF/Department and clinic of field therapy
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
City
Saint Petersburg
ZIP/Postal Code
194358
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Institution of Health "City Polyclinic № 54"
City
Saint Petersburg
ZIP/Postal Code
195197
Country
Russian Federation
Facility Name
Road Clinical Hospital JSC Russian Railways
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Limited Liability Company Gastroenterologichesky Center Expert
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Institution of Health "City Polyclinic № 106"
City
Saint Petersburg
ZIP/Postal Code
198328
Country
Russian Federation
Facility Name
Pokrovskaya City Hospital
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
St. Petersburg State Budgetary Institution of Health "City Polyclinic №4"
City
Saint Petersburg
ZIP/Postal Code
199178
Country
Russian Federation
Facility Name
Samara city hospital #4
City
Samara
ZIP/Postal Code
443056
Country
Russian Federation
Facility Name
LLC Center "Diabetes"
City
Samara
ZIP/Postal Code
443067
Country
Russian Federation
Facility Name
Saratov State Medical University named after V. I. Razumovsky
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Volgograd State Medical University
City
Volgograd
ZIP/Postal Code
400131
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Consultative and Diagnostic Center
City
Voronezh
ZIP/Postal Code
394018
Country
Russian Federation
Facility Name
LLC "Medical Consultations and Research Center - PRACTICE"
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
The State Budgetary Healthcare Institution of the Yaroslavl Region "Regional Clinical Hospital"
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation

12. IPD Sharing Statement

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Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance

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